Vinorelbine and Gemcitabine in Myeloma

NCT02791373 | Completed Phase 2

• 1 other identifier: ViGeM
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the efficacy of gemcitabine is comparable with the efficacy of the standard chemotherapy with vinorelbine for mobilization of autologous stem cells in myeloma patients

Conditions

Multiple Myeloma; Amyloidosis

Outcome Measures

Primary Outcomes (1)

• CD34+ (cluster of differentiation 34) peripheral blood stem cells

  Number of patients with collection of \> 6 million CD34+ peripheral blood stem cells/kg body weight at day 8 after vinorelbine versus gemcitabine chemotherapy

  Day 8

Secondary Outcomes (6)

• Rate of peripheral neuropathy

  Between 15 and 30 days

• Severity of peripheral neuropathy

  Between 15 and 30 days

• Hematologic recovery

  Between 15 and 30 days

• Minimal residual disease in the peripheral blood

  Day 8

• Need to use the stem cell releasing compound Plerixafor

  Day 8

Study Arms (2)

Mobilisation Chemotherapy: Vinorelbine

ACTIVE COMPARATOR

Vinorelbine is given at a standard dose of 35mg/m2 i.v. at day 1 as an infusion over 10 minutes, on an ambulatory basis.

Drug: Vinorelbine

Mobilisation Chemotherapy: Gemcitabine

EXPERIMENTAL

Gemcitabine is given at the standard dose of 1250 mg/m2 i.v. in 500ml NaCl 0.9% (sodium chloride) as an infusion over 30 minutes, on an ambulatory basis.

Drug: Gemcitabine

Interventions

Vinorelbine DRUG

Mobilisation Chemotherapy

Also known as: Navelbine

Mobilisation Chemotherapy: Vinorelbine

Gemcitabine DRUG

Mobilisation Chemotherapy

Also known as: Gemcitabine Sandoz

Mobilisation Chemotherapy: Gemcitabine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic myeloma or amyloidosis patients after standard first-line induction treatment. Patients must be fit for subsequent consolidation with high-dose chemotherapy with melphalan with autologous stem cell support.
• Standard induction chemotherapy comprises regimens including thalidomide, bortezomib, or lenalidomide (less than 5 cycles), alone or in combination with dexamethasone. Combinations of novel agents are allowed as well as induction with the VAD (vincristine, adriamycin and dexamethasone) regimen.
• Patient must be aged 18-75 years, with an ECOG (Eastern Cooperative Oncology Group) \< 3, and has given voluntary written informed consent.
• Patient has the following laboratory values at baseline:
• Platelets count \> 50 x 109/l without transfusion support within 7 days before the laboratory test.
• Absolute neutrophil count (ANC) \> 1.0 x 109/l without the use of colony stimulating factors.
• Creatinine-clearance \> 40 ml/min
• Negative pregnancy test (urine or serum) within 14 days prior to registration for all women of childbearing potential. Patients of childbearing potential must implement adequate measures (hormonal treatment p.o. or i.m., intra uterine surgical devices, or latex condoms) to avoid pregnancy during study treatment and for additional 12 months. No pregnant or lactating patients are allowed.

You may not qualify if:

• Patients with more than 4 cycles of chemotherapy with lenalidomide.
• Patients not fit for autologous stem cell transplantation
• Patients with other serious medical condition that could potentially interfere with the completion of treatment according to this protocol or that would impair tolerance to therapy or prolong hematological recovery.
• Subject is currently enrolled in another investigational trial or is receiving other investigational agent(s).

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department for Medical Oncology; University Hospital/Inselspital

Bern, 3010, Switzerland

Location

Related Publications (1)

• Attal M, Harousseau JL, Stoppa AM, Sotto JJ, Fuzibet JG, Rossi JF, Casassus P, Maisonneuve H, Facon T, Ifrah N, Payen C, Bataille R. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Francais du Myelome. N Engl J Med. 1996 Jul 11;335(2):91-7. doi: 10.1056/NEJM199607113350204.

  PMID: 8649495 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma; Amyloidosis

Interventions

Vinorelbine; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Thomas Pabst, MD

  Inselspital , University Hospital Berne

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 6, 2016
• Study Start: March 1, 2014
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: April 3, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)